Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710940
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2020-12-29
Brief Title:
Development and Feasibility Testing of DM-BOOST Intervention
Sponsor:
Daniel Amante
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Development and Feasibility Testing of a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DM-BOOST
Brief Summary:
DM-BOOST uses clinical informatics tools to identify types of patients with gaps in diabetes care and deploy tailored proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance longitudinal patient self-management support
Detailed Description:
In DM-BOOST the Principal investigator will deploy a mixed-methods patient-centered approach to intervention development and initiate a multiphase optimization strategy MOST to learn how to maximize patient engagement and support of self-management training In this pilot study team will complete the first phase Preparation and initiate feasibility piloting of the second phase Optimization Completion of optimization and MOSTs final phase Evaluation will occur in a subsequent project
In the preparation phase Principal investigator will first analyze EHR and claims data in the UMCCTS data lake to identify sociodemographic characteristics associated with gaps in diabetes care to develop patient persona archetypes Aim 1 Next Principal investigator will selectively recruit patients of identified persona types as consultants elicit stakeholder feedback during community engagement studios and conduct usability testing to iteratively design the intervention Aim 2 Study team will then conduct a feasibility pilot Aim 3 to assess user experience of the intervention implementation and collect exploratory outcome data to be used to inform a subsequent complete optimization trial
In the preparation phase Principal investigator will first analyze EHR and claims data in the UMCCTS data lake to identify sociodemographic characteristics associated with gaps in diabetes care to develop patient persona archetypes Aim 1 Next Principal investigator will selectively recruit patients of identified persona types as consultants elicit stakeholder feedback during community engagement studios and conduct usability testing to iteratively design the intervention Aim 2 Study team will then conduct a feasibility pilot Aim 3 to assess user experience of the intervention implementation and collect exploratory outcome data to be used to inform a subsequent complete optimization trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None